Actively Recruiting

All Genders
Healthy Volunteers
NCT03052283

Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score)

Led by Medizinische Hochschule Brandenburg Theodor Fontane · Updated on 2023-04-04

2000

Participants Needed

2

Research Sites

570 weeks

Total Duration

On this page

Sponsors

M

Medizinische Hochschule Brandenburg Theodor Fontane

Lead Sponsor

U

University of Jena

Collaborating Sponsor

AI-Summary

What this Trial Is About

Development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease Cystic fibrosis. In the stepwhise development of the patient reported outcome measures (PROM) repeadedly, CF-patients, their families as well as professionals working in different fields of CF-care will be included.

CONDITIONS

Official Title

Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score)

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of cystic fibrosis confirmed by a sweat chloride test over 60 mEq/L and/or detection of two disease-causing CFTR mutations with evidence of organ involvement
  • Age-matched healthy controls for comparison
  • Ability of patients or their families to cooperate with the study procedures
Not Eligible

You will not qualify if you...

  • Lack of ability to cooperate by patients or their families
  • Healthy controls with other diseases causing abdominal symptoms such as inflammatory bowel disease, alpha 1 antitrypsin deficiency, celiac disease, food allergy, or gastroenteritis

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Klinikum Westbrandenburg

Brandenburg an der Havel, Germany, 14770

Actively Recruiting

2

Medizinische Hochschule Brandenburg (MHB), University

Brandenburg an der Havel, Germany, 14770

Actively Recruiting

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Research Team

J

Jochen G Mainz, Prof. MD

CONTACT

F

Franziska Duckstein, MA

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score) | DecenTrialz